Behavioral and Pharmacological Reconsolidation Interference in Misophonia (Miso Prop)

Mount Sinai Health System

Status and phase: Completed; Early Phase 1

Conditions: Misophonia

Treatments: Drug: Propranolol Hydrochloride tablet; Drug: Placebo; Behavioral: Counterconditioning; Behavioral: Reminder

Study type: Interventional

Funder types: Other

Identifiers

NCT05928689

STUDY-22-01280

Details and patient eligibility

About

One of the core processes presumably underlying misophonia - a condition characterized by decreased tolerance for specific sounds - is associative learning. Using behavioral, computational, and neural analyses of emotional learning and memory processes to understand the unknown behavioral and neural mechanisms underlying misophonia's associative learning and memory, the study team will evaluate whether interference with the reconsolidation of a reactivated misophonia memory with propranolol can alleviate aversive reaction to misophonia-related cues.

Enrollment: 141 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear.
• Must be between the ages of 18 - 55.
• Must be fluent in English since the study's instructions, surveys, and tasks will be in English

Exclusion criteria

• Disability or medical condition that prohibits completion of study. Participants must be able to complete all study procedures to ensure optimal conditions for data analysis.
• CNS disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, history of head trauma (defined as loss of consciousness>3 min), or history of seizures without a resolved etiology. CNS disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity. We wish to minimize confounding variables.
• Recently used drugs of abuse.
• Pregnancy. The risks associated with neither propranolol exposure during gestation have been studied extensively. We wish to safeguard the health of potential participants and their children.
• Lactation. Propranolol is excreted in human breast-milk, and its impact on infant development has not been studied. We wish to safeguard the health of potential participants and their children.
• Regular use of medication metabolized in the CYP2D6, 1A2, or 2C19 pathways. Drugs that are metabolized in the same pathway as propranolol may increase its efficacy or toxicity. We wish to safeguard the health of participants.
• Blood pressure over 150/100 or under 100/60 (applicable for either systolic or diastolic measures) and any hypertension requiring medication. Propranolol is known to pose additional risk to individuals with a number of medical conditions. We wish to safeguard the health of our participants.
• Pulse over 100 or under 55.
• History of cardiovascular illness such as cardiac arrhythmia, coronary heart disease or any cardiac dysfunction that requires medication.
• Active respiratory illness including bronchospastic pulmonary disease and chronic obstructive pulmonary disease
• Diabetes mellitus.
• Other medical conditions that make it unsafe to take propranolol (e. g. allergy to propranolol).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

141 participants in 5 patient groups, including a placebo group

Memory Reminder followed by Propranolol Hydrochloride

Experimental group

Description:

This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a propranolol hydrochloride tablet.

Treatment:

Behavioral: Reminder

Drug: Propranolol Hydrochloride tablet

Memory reminder followed by Placebo

Placebo Comparator group

Description:

This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a placebo tablet.

Treatment:

Behavioral: Reminder

Drug: Placebo

No memory reminder followed by Propranolol Hydrochloride

Experimental group

Description:

This arm aims to have 30 participants with a pharmacological manipulation. They will not receive a reminder to reactivate their memory of a misophonia sound and only receive a propranolol hydrochloride tablet.

Treatment:

Drug: Propranolol Hydrochloride tablet

Memory reminder followed by counterconditioning

Experimental group

Description:

This arm aims to have 30 participants with a behavioral manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger and then will undergo counterconditioning.

Treatment:

Behavioral: Reminder

Behavioral: Counterconditioning

No memory reminder followed by counterconditioning

Experimental group

Description:

This arm aims to have 30 participants with a behavioral manipulation. They will not receive a reminder to reactivate their memory of a misophonia trigger and then undergo counterconditioning.

Treatment:

Behavioral: Counterconditioning